Hepatic And Renal Safety Profile
Clinical studies suggest that ibuprofen was associated with less acute liver injury compared to other NSAIDs:
Archives of Internal Medicine, 1994
- The lowest incidence of liver injury among 8 NSAIDs occurred in ibuprofen users and was 1.6/100000 . The other incidence in increasing order is as follows: oral diclofenac , naproxen , mefenamic acid , ketoprofen , piroxicam , fenbufen , sulindac 12
Postgraduate Medicine, 2018
- Compared to ibuprofen, risks of hepatoxicity are somewhat higher and better documented with acetaminophen, and reported to be higher amongst specific NSAIDs, such as oral diclofenac and sulindac13
Epidemiologic studies do not suggest that low dose ibuprofen is associated with an increased risk of renal adverse events
American Journal of Epidemiology, 2000
- Use of ibuprofen at 1200mg/day led to an odds ratio of 0.94 for renal AEs 9
Pharmacotherapy, 1999
- No major adverse events related to renal injury were identified during the study10
Pharmacotherapy, 1992
- After non-prescription doses of ibuprofen, renal injury were not amongst the reported adverse effects11
AE = adverse event CI = confidence interval GI = gastrointestinal NSAID = nonsteroidal anti-inflammatory drug OTC = over the counter.
How Should I Take Advil Cold & Sinus
Use exactly as directed on the label, or as prescribed by your doctor. An overdose of ibuprofen can damage your stomach or intestines.
Take Advil Cold & Sinus with food or milk to lessen stomach upset.
If you need surgery, tell the surgeon ahead of time if you have taken this medicine within the past few days.
Store at room temperature away from moisture and heat.
Clinically Proven Efficacy In Sore Throat Pain
Ibuprofen offered statistically significant effective sore throat relief in the following study:
Clinical Pharmacology and Therapeutics, 1988
- A double-blind, single dose parallel study was conducted to evaluate treatment of sore throat pain. Ibuprofen was more effective on all rating scales from 180 to 360 minutes vs. acetaminophen and at all time points vs. placebo .14*
*Schachtel BP et al conducted a double-blind, single-dose parallel study of patients with tonsillopharyngitis who randomly received either 400 mg ibuprofen, 1000 mg acetaminophen or placebo. At hourly intervals for 6 hours, patients reported pain intensity and pain relief on conventional scales and two sensory qualities of throat pain on two new visual analogy scales.
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Advil Cold & Sinus Side Effects
Get emergency medical help if you have signs of an allergic reaction or a severe skin reaction .
Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, leg swelling, feeling short of breath.
Stop using Advil Cold & Sinus and call your doctor at once if you have:
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confusion, severe drowsiness, ringing in your ears, severe dizziness, feeling like you might pass out
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fast, pounding, or uneven heartbeat
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easy bruising or bleeding
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a skin rash, no matter how mild
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signs of stomach bleeding–bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds
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liver problems–loss of appetite, stomach pain , tiredness, itching, dark urine, clay-colored stools, jaundice
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kidney problems–little or no urination, swelling in your feet or ankles, feeling tired or short of breath or
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nerve problems–fever, headache, neck stiffness, chills, increased sensitivity to light, seizure .
Common side effects of Advil Cold & Sinus may include:
How Bad Is It To Take Expired Medication
Like mentioned above, taking expired medication is risky. We advise against taking expired medication because medication can become less effective after the expiration date. In addition, there is the risk of possible changes in the medications chemical composition or a decrease in potency. According to the FDA, once the expiration date has passed there is no guarantee that the medicine will be safe and effective.i
Expired medicines are a danger to the person they were prescribed to and to others in the household if taken by mistake.i
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What To Do If You Miss A Dose Of Advil Cold/sinus
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Keep all medicine out of the reach of children. Never share your medicine with anyone.
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Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
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Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
When Used As Directed For Acute Pain Otc Ibuprofen Is Well Tolerated2*
In the PAIN study, which included over 8,500 patients, total GI events and abdominal pain were less frequent with ibuprofen compared to ASA or acetaminophen ) 2,3
This large-scale randomized trial comparing nonprescription doses of ASA, acetaminophen, and ibuprofen in 8,677 adults measured rates of significant adverse events related to tolerability. The primary outcome measure was the number of patients with at least one significant adverse event, defined as an event that was serious, severe or moderate, resulted in a second physician consultation, led to cessation of treatment, or was of missing intensity. Statistical analysis tested for equivalence between ibuprofen and acetaminophen, and for difference with ASA.2,3*
GI: gastrointestinal ASA: acetylsalicylic acid OTC = over the counter.
* This was a blinded, multicentre study in general practice of up to 7 days of ASA, acetaminophen or ibuprofen , administered for common painful conditions, using patient generated data with physician assistance. 1,108 general practitioners included 8,677 adults . The main indications were musculoskeletal or back pain , sore throat, the common cold and flu .
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Labelling Error May Cause People To Mix Up Day And Night Tablets
Two lots of Advil’s Cold & Sinus Day/Night Convenience Pack are being recalled due to a labelling error.
The problem involves one lot of 18-caplet boxes and one of 36-caplet boxes.
The foil backing on the blister pack is upside down and misaligned so the nighttime caplets are labelled as daytime and some daytime caplets are labelled as nighttime.
There are concerns consumers may get the medications mixed up.
Health Canada says mistakenly taking a nighttime caplet could result in serious health consequences for those who need to remain alert, such as when driving, or who have taken other sedatives, consumed alcohol or are elderly.
The affected products were distributed in Canada starting last July. The lot numbers are ER2072 or ER2069, both with expiry dates of February 2023.
With files from CBC News
What You Should Do
- Stop using the recalled products. Consult a health care professional if you have used any of these products and have health concerns.
- Follow municipal or regional guidelines on how to dispose of chemicals and other hazardous waste or
- Return the product to your local pharmacy for proper disposal.
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When To Use Advil Cold & Sinus
Nasal and sinus congestion are symptoms of the common cold or flu. The decongestant in Advil Cold & Sinus relieves congestion to help relieve your stuffy nose and ibuprofen relieves pain. Advil Cold & Sinus is a safe, non-prescription drug that can be used by people 12 years and older. Its available behind the pharmacy counter at your local drugstore or grocery store. As with all medications, make sure to read all directions to ensure the proper usage and if you have any concerns, consult your physician.
Sarah Wants Effective Relief For Her Sore Throat And Other Common Cold Symptoms
Sarah* has two young children who require constant supervision. She has had a fever for a day and woke up this morning to symptoms of a sore throat, sinus pain and body ache. Since she works from a home office and is on virtual calls or on her phone frequently, she needs to be extra alert of balancing the needs of her family even though she is suffering from the symptoms of a cold or flu. Sarah is hoping for effective relief, especially from her sore throat, so she can stay on top of everything.
Her symptoms: Sore throat, sinus pain, body ache and fever.
Advil Cold, Sinus and Flu Extra Strength is indicated to treat pain and fever related to a cold and flu. Studies have demonstrated a proven effect of Advil on:1,2
- sore throat pain
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Advil Cold And Sinus Tablets Recalled In Canada Due To Labelling Mix
Two lots of Advil tablets have been recalled in Canada due to a labelling error that may lead to some caplets being taken at the wrong time of day.
Health Canada announced the recall on Sunday, saying it concerns two specific lots of the Advil Cold & Sinus Day/Night Convenience Pack boxes.
Affected boxes contain either 18 caplets or 36 caplets , and have an expiration date of February 2023.
Health Canada says they were sold across the country starting in July 2021.
The issue, according to manufacturer GlaxoSmithKline Consumer Healthcare, is that the foil backing on the medicine’s packaging was printed upside-down and misaligned. As a result, beige caplets meant to be taken at night are mislabelled as daytime caplets, and some orange daytime caplets are mislabelled as nighttime caplets.
“Taking a nighttime caplet when alertness is required may pose potentially serious adverse health consequences, such as when driving motor vehicles or operating heavy machinery. It may also cause potentially serious health consequences for those who have taken other sedatives or tranquilizers, consumed alcohol, and the elderly,” Health Canada’s recall notice states.
It is recommended that anyone who has Advil products covered by the recall stop using them, and consult with a health-care professional if they have health-related concerns. Recalled products can also be returned to the point of purchase.
I Took A Dose Of Advil Cold And Sinus Then Two Hours Later Took A Dose Of Advil Pm Is That Ok
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Before Taking This Medicine
Ibuprofen can increase your risk of fatal heart attack or stroke, even if you don’t have any risk factors. Do not use this medicine just before or after heart bypass surgery .
Ibuprofen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using Advil Cold & Sinus, especially in older adults.
You should not use this medicine if you are allergic to ibuprofen or pseudoephedrine, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.
Do not use Advil Cold & Sinus if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, tranylcypromine, and others.
Do not give ibuprofen to a child younger than 12 years old.
Ask a doctor or pharmacist if this medicine is safe to use if you have ever had:
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enlarged prostate, urination problems.
If you are pregnant, you should not take Advil Cold & Sinus unless your doctor tells you to. Taking an NSAID during the last 20 weeks of pregnancy can cause serious heart or kidney problems in the unborn baby and possible complications with your pregnancy.
Ask a doctor before using this medicine if you are breastfeeding.
How Does Advil Cold And Sinus Work
Treatment Options
Many people attribute the stuffiness associated with the cold or the flu to an increase in mucus which blocks their airways. While it is true that increased mucus is a symptom of the common cold, it is not always what causes you to feel so stuffed up. Instead, the true source of nasal and sinus congestion is often caused by inflammation of the tissues throughout the nose and face. When the body identifies a virus it considers a threat, it springs to defense in various ways, one of which is by causing the airways within the nose and sinuses to swell and become inflamed.
Advil Cold & Sinus is a combination of pseudoephedrine and ibuprofen . The two work together to reduce nasal and sinus congestion caused by inflammation and lessen the pain associated with the common cold or the flu.
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Ibuprofen Comparative Tolerability In A Large
In the PAIN study, published in Clinical Drug Investigation, overall tolerability of ibuprofen was:2,3
- Statistically equivalent to that of acetaminophen
- Superior to that of ASA
This large-scale randomized trial comparing nonprescription doses of ASA, acetaminophen, and ibuprofen in 8,677 adults measured rates of significant adverse events related to tolerability. The primary outcome measure was the number of patients with at least one significant adverse event, defined as an event that was serious, severe or moderate, resulted in a second physician consultation, led to cessation of treatment, or was of missing intensity. Statistical analysis tested for equivalence between ibuprofen and acetaminophen and for difference with ASA.2,3*
ASA = acetylsalicylic acid GI = gastrointestinal.* This was a blinded, multicentre study in general practice of up to 7 days of ASA, acetaminophen or ibuprofen , administered for common painful conditions, using patient generated data with physician assistance. 1,108 general practitioners included 8,677 adults . The main indications were musculoskeletal or back pain , sore throat, the common cold and flu .
What Is Advil Cold & Sinus
Ibuprofen is a nonsteroidal anti-inflammatory drug . Pseudoephedrine is a decongestant.
Advil Cold & Sinus is a combination medicine used to treat stuffy nose, sinus congestion, cough, and pain or fever caused by the common cold or flu.
Advil Cold & Sinus may also be used for purposes not listed in this medication guide.
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